Brief Title
Avatar-Directed Chemotherapy in Treating Patients With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Official Title
Avatar-Directed Chemotherapy in Platinum-Resistant Ovarian, Primary Peritoneal and Fallopian Tube Cancers
Brief Summary
This phase II trial studies how well Avatar-directed chemotherapy works in treating patients
with ovarian, primary peritoneal, or fallopian tube cancer that does not respond to platinum
anti-cancer drugs. Drugs used in chemotherapy, such as paclitaxel, gemcitabine hydrochloride,
pegylated liposomal doxorubicin hydrochloride, topotecan hydrochloride, work in different
ways to stop the growth of tumor cells, either by killing the cells, by stopping them from
dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may
interfere with the ability of tumor cells to grow and spread. Using an Avatar, a living tumor
sample with similar genetic characteristics to the original tumor, may help determine which
chemotherapy is most effective.
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the response rate of Avatar-directed salvage chemotherapy in patients with
platinum-resistant ovarian, primary peritoneal and fallopian tube cancers.
SECONDARY OBJECTIVES:
I. To determine the progression-free survival of patients with platinum-resistant ovarian,
primary peritoneal and fallopian tube cancers receiving Avatar-directed salvage chemotherapy.
II. To determine the overall survival of patients with platinum-resistant ovarian, primary
peritoneal and fallopian tube cancers receiving Avatar-directed salvage chemotherapy.
III. To determine the adverse events for patients with platinum-resistant ovarian, primary
peritoneal and fallopian tube cancers receiving Avatar-directed salvage chemotherapy.
IV. To determine the correlation between patient response and response in their Avatar.
V. To enrich the Avatar response signature in response to Avatar-directed therapy using
patient outcomes.
VI. To compare the response rates between patients who did or did not receive bevacizumab
treatment.
OUTLINE: Patients are assigned to 1 of 4 treatment arms as directed by Avatar results.
ARM A: Patients receive paclitaxel intravenously (IV) over 1-96 hours on days 1, 8, and 15.
Patients may also receive bevacizumab IV over 90 minutes on days 1 and 15. Courses repeat
every 28 days in the absence of disease progression or unacceptable toxicity
ARM B: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ARM C: Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on
day 1. Patients may also receive bevacizumab IV over 90 minutes on days 1 and 15. Courses
repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ARM D: Patients receive topotecan hydrochloride IV over 30 minutes on days 1-5 every 21 days
or days 1, 8, and 15 every 28 days. Patients may also receive bevacizumab IV over 90 minutes
on day 1 every 21 days or days 1 and 15 every 28 days. Courses repeat every 21 or 28 days in
the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3-6 months for 3 years.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Proportion of patients with a confirmed tumor response, defined as complete response or partial response estimated using Response Evaluation Criteria in Solid Tumors 1.1 criteria
Secondary Outcome
Incidence of adverse events (AE)
Condition
Recurrent Fallopian Tube Carcinoma
Intervention
Bevacizumab
Study Arms / Comparison Groups
Arm A (Avatar-directed paclitaxel)
Description: Patients receive paclitaxel IV over 1-96 hours on days 1, 8, and 15. Patients may also receive bevacizumab IV over 90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
240
Start Date
July 21, 2015
Completion Date
June 2021
Primary Completion Date
June 2021
Eligibility Criteria
Inclusion Criteria:
- Histologic confirmation of ovarian, primary peritoneal or fallopian tube cancer of any
subtype
- Prior consent to have tumors used for unspecified future research
- Ability to provide written informed consent
- Willing to agree to periodic contact with a member of the study team during the period
that the cancer has not recurred and/or has not become platinum resistant
- Willing to agree that the local medical oncologist may be informed that patient has
agreed to participate in the study
- Platinum resistant or refractory ovarian, primary peritoneal or fallopian tube cancer
of any subtype; Note: platinum-sensitive disease is allowed in cases where there is a
contraindication to platinum-based therapy (i.e., allergy to platinum); this must be
reviewed and approved by the Principal Investigator
- Successful Avatar engraftment with successful expansion and treatment outcome of
Avatar therapy
- Eastern Cooperative Oncology Group (ECOG) performance status (ECOG performance status
[PS]) of 0, 1 or 2
- Measurable disease or non-measurable disease; for patients with non-measureable
disease, they must also have a cancer antigen (CA)-125 measurement of > 35 U/mL or 2 X
their documented nadir on 2 separate measurements 1 week apart
- The following laboratory values obtained =< 21 days prior to registration; complete
blood count (CBC), sodium, potassium, aspartate aminotransferase (AST), bilirubin and
creatinine are to be obtained pre-study; Note: treatment initiation and dosing
modification should be performed at the individual investigators discretion and be
consistent with the product label and their medical practice
- Negative urine or serum pregnancy test performed =< 7 days prior to registration, for
women of child bearing potential only
- Willing to return to enrolling institution for follow-up or have a local physician
willing to submit response and outcome data; Note: any and all therapy, potentially in
its entirety, may be conducted outside of the Mayo Clinic
Exclusion Criteria:
- Any of the following:
- Pregnant women
- Nursing women
- Prior treatment with Doxil, topotecan, Gemzar or Taxol chemotherapy for
platinum-resistant cancer; Note: Allowed prior therapy with Doxil or Gemzar if given
for platinum sensitive disease in combination with a platinum drug AND the Avatar data
indicates a drug other than Doxil or Gemzar would be effective; Note: Allowed prior
therapies for patients following confirmation of platinum-resistant cancer include:
- Therapeutic antibodies, such as bevacizumab
- Small molecule kinase inhibitors, such as pazopanib
- Vaccines and immunotherapy All of these exceptions should be confirmed with the
Principal Investigator (PI) prior to registration
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment
of the investigator, would make the patient inappropriate for entry into this study or
interfere significantly with the proper assessment of safety and toxicity of the
prescribed regimens
- Immunocompromised patients and patients known to be human immunodeficiency virus (HIV)
positive and currently receiving antiretroviral therapy; Note: patients known to be
HIV positive, but without clinical evidence of an immunocompromised state, are
eligible for this trial
- Uncontrolled intercurrent illness judged by the treating investigator to preclude
treatment with chemotherapy
- Receiving any other investigational agent which would be considered as a treatment for
the primary neoplasm
- Other active malignancy =< 3 years prior to registration; EXCEPTIONS: non-melanotic
skin cancer or carcinoma-in-situ of the cervix; Note: if there is a history of prior
malignancy, they must not be receiving treatment for their cancer
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Saravut Weroha, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02312245
Organization ID
MC1463
Secondary IDs
NCI-2014-02399
Responsible Party
Sponsor
Study Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Saravut Weroha, Principal Investigator, Mayo Clinic
Verification Date
July 2020